Pregnant Women, Fetuses, and Neonates Involved as Participants in Research- PRO132   

Procedure
 

Investigator Responsibilities

• Completes the FOR200 IRB application eForm:
  • Indicates pregnant women, fetuses, neonates will be a target population for research activities; and
  • Addresses obtaining informed consent process and selection of participants with particular attention to preventing undue influence or coercion.

OIRB Responsibilities

Reviewing Staff:

• Discusses and/or assesses whether the protocol meets the criteria for research involving after delivery, the placenta, the dead fetus or fetal material and whether it
  • Represents human subjects research requiring IRB review, or
  • Appears to meet the criteria for Not Human Subjects Research designation, and if so refers research to the OIRB Director (see FOR202 Application for Not Human Subjects Research Designation);
  • Ensures that the research is consistent with Alabama state law (see GUI326).
• Reviews the HSP using the appropriate OIRB checklist (see checklists: GUI308 New Convened, GUI309 or GUI343 New Expedited, GUI310 Continuing Convened, GUI311 Continuing Expedited) to ensure the following:
  • All required materials were submitted with the IRB application eForm for Subpart A (see PRO122 Procedure for Initial Review of Proposed Research at the Convened IRB Meetings, PRO120 Procedure for Initial Review Using the Expedited Procedure, PRO147 Procedure for Continuing Review of Research Approved by the Convened IRB, PRO150 Procedure for Continuing Review of Research by the Expedited Procedure);
  • The additional required information is provided to satisfy Subpart B for research activities involving pregnant women, fetuses, neonates;
  • For HHS-funded research, reviews to see if criteria under 42 U.S.C. Secs. 289g (fetal research), 289g-1 (research on transplantation of fetal tissue), and 289g-2 (prohibitions regarding human fetal tissue) are met;
• Contacts investigator and/or study coordinator with questions or needed clarification/documentation regarding the population;
• Assures that the IRB discusses and makes the required determinations under 45 CFR 46.204 or 46.205, when applicable;
• For HHS-funded research that the IRB believes is not approvable under 45 CFR 46.204 or 46.205, but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses or neonates:
  • Refers to the HHS Secretary through OHRP for determination on the conduct and/or funding of the research under 45 CFR 46.207.
• Notifies the OIRB Director within 5 days when the IRB finds the protocol meets 45 CFR 46.207(a);
• Verifies that discussion and determinations of the IRB are reflected in the minutes;
• Reviews the IRB minutes, including the IRB’s protocol-specific findings justifying waiver of the consent process or waiver of documentation of consent;
• Issues approval only after all the criteria in subparts A and B are satisfied.

Administrative Staff:

• Assists reviewing staff in preparing the letter of determination to the investigator.
• Documents discussion and required determinations of the IRB in the minutes as described under the responsibilities for the reviewing staff.
• Issues approval and informed consent documents through the electronic research administration (ERA) system.

IRB Responsibilities

Primary Reviewer(s):

• Reviews the protocol at the time of initial or continuing review;
• Completes (GUI319) the checklist for pregnant women and fetuses and presents the protocol, including the additional protections for pregnant women, fetuses, neonates/nonviable neonates.

Convened IRB or Experienced Reviewer:

• Reviews the proposed research, informed consent process, and other applicable documents to determine whether the study meets criteria at 45 CFR 46.111, and 21 CFR 56.111 if applicable, for approval by the convened IRB or expedited review procedure;
• Discusses the proposed research—taking into consideration all applicable UAB policies and procedures, state laws, and the additional requirements for pregnant women, fetuses, neonates, and nonviable neonates to participate in research described in 45 CFR 46 Subpart B—including whether:
  • The protocol meets the criteria for pregnant women or fetuses under 45 CFR 46.204; or
  • The protocol meets the criteria for neonates of uncertain viability and nonviable neonates under 45 CFR 46.205, and
    • If the protocol is funded by HHS and involves fetal research, the criteria of 42 U.S.C. Sec. 289g are satisfied; or
  • The protocol meets the criteria for research involving, after delivery, the placenta, the dead fetus or fetal material, and
    • If the protocol is funded by HHS and involves transplantation of human fetal tissue, the criteria of 42 U.S.C. Secs. 289g-1 and 289g-2 are satisfied; or
  • The IRB believes the protocol is not approvable under the criteria above, but finds the research presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses or neonates, and
    • If the research is funded by HHS, refers the protocol to OHRP for a determination under 45 CFR 46.207(b); defers further action until a response is received from OHRP; reviews any changes proposed by OHRP through the response review process; and takes final action on the protocol at that time;
    • If the research is not funded by HHS, approves the research only if it determines the following are satisfied: (i) the research is conducted in accordance with sound ethical principles and (ii) informed consent will be obtained in accordance with 45 CFR 46 Subpart A and all applicable additional subparts.
• Issues approval only when all applicable sections of 45 CFR Part 46 subparts A and B are satisfied.